CFR section
21 CFR 211.194(a)(8): Laboratory records
PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS · Subpart J-Records and Reports
Key facts
| Citation | 21 CFR 211.194(a)(8) |
|---|---|
| Section | Laboratory records |
| Part | PART 211-CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS |
| Subpart | Subpart J-Records and Reports |
| Subchapter | 21 CFR C Drugs General |
| Product types cited | Biologics, Devices, Drugs, Food/Cosmetics, General, Other_Regulations |
| Regulation text (excerpt) | (8) The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. |
At a glance
- 100–999 Inspections citing this section
- 10–99 Warning letters citing this section
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.